Randomised, double-blinded, placebo-controlled trial assessing the efficacy of Mi-Gel® in the treatment of women with vulval pain / entry dyspareunia.

This research study is for women with a diagnosis of vulval pain / entry dyspareunia (pain at the level of the vaginal entry). Entry dyspareunia has a variety of causes and can be linked to pudendal neuralgia, hypoestrogenism or vulvodynia. Vulvodynia is described as vulvar pain of at least 3 months duration, without clear identifiable cause. Pudendal neuralgia, like vulvodynia, is a nerve pain condition diagnosed in the absence of other causes. Amitriptyline is an effective pain medication that is often used orally (in a tablet) for the treatment of nerve pain. However, this is sometimes not well tolerated due to side effects. When applied topically (directly onto the affected area) instead of orally, amitriptyline works locally, on nerves where it is applied, and there is evidence that it is better tolerated. Oestriol is one of the three main oestrogens produced naturally by the body. We have found that many of our patients with entry dyspareunia, pudendal neuralgia and vulvodynia have skin changes suggestive of low oestrogen levels. Treatment with topical oestrogen improves skin health and can reduce pain. This study will assess the effectiveness of a topical gel containing both amitriptyline and oestriol in the treatment of this pain. The study is designed to measure the effect the treatment has on pain as a result of entry dyspareunia; bladder function; sexual function; and whether it causes any adverse effects. The study hypothesis is that the use of Mi-Gel will result in a statistically significant reduction in vulval pain, as measured by the Numeric Rating Scale (NRS) change from baseline at Week 12, compared to placebo.